Moxetumomab pasudotox

Moxetumomab pasudotox is an anti-CD22 immunotoxin designed for the treatment of cancer.[1]

Moxetumomab pasudotox
Monoclonal antibody
TypeWhole antibody
SourceMouse
TargetCD22
Clinical data
ATC code
  • none
Identifiers
CAS Number
ChemSpider
  • none
UNII
Chemical and physical data
FormulaC2804H4339N783O870S14
Molar mass63.5 kg/mol g·mol−1
 NY (what is this?)  (verify)

Moxetumomab pasudotox is currently being developed by the biologics division of AstraZeneca, MedImmune.

On 16 May 2013, the first dose in a Phase III trial was administered.[2][3]

In Sept 2018 the US FDA approved it (as Lumoxiti) for some cases of relapsed or refractory hairy cell leukemia (HCL).[4]

Discovery and ownership background

On the 1 November 2005 Cambridge Antibody Technology (CAT) announced it was acquiring two anti-CD22 immunotoxin products from Genencor, namely GCR-3888 and GCR-8015.[5] Genencor is the biotechnology division of Danisco[6] and the acquisition meant CAT would hire certain former Genencor key employees to be responsible for the development of the programmes.[7]

GCR-3888 and GCR-8015 were discovered and initially developed by the National Cancer Institute, which is part of the U.S. National Institutes of Health. Genencor licensed the candidates for hematological malignancies and entered into a Cooperative Research and Development Agreement (CRADA) with the NIH, which will now be continued by CAT. Under the original license agreement with the NIH, CAT gained the rights to a portfolio of intellectual property associated with the programs and would pay future royalties to the NIH.

CAT intended to file an Investigational New Drug (IND) application for GCR-8015 in various CD22 positive B-cell malignancies, including Non-Hodgkin lymphoma and chronic lymphocytic leukemia, following a period of manufacturing development which is expected to be complete by the end of 2006 and to support the NCI's ongoing development of GCR-3888 in Hairy cell leukemia (HCL) and pediatric acute lymphoblastic leukemia (pALL).[5]

CAT-8015 exhibited a greater affinity for CD22 than its predecessor, CAT-3888[8] and CAT's language such as "CAT will support the NCI's ongoing development of CAT-3888..." suggested at the time that their focus was on the second generation candidate.[9]

CAT was acquired by AstraZeneca, who also acquired MedImmune, combining the two into a biologics division. MedImmune renamed CAT-8015 to moxetumomab pasudotox.[10][11]

On the 16 May 2013, AstraZeneca announced that CAT-8015 had started Phase III clinical trials.[2]

References
  1. "US FDA accepts Biologics License Application for moxetumomab pasudotox in hairy cell leukaemia". Astrazeneca.
  2. https://www.bloomberg.com/news/2013-05-16/astrazeneca-advances-three-cancer-drugs-into-late-stage-trials.html
  3. https://www.reuters.com/article/2013/05/16/us-cancer-astrazeneca-idUSBRE94F0DU20130516
  4. FDA approves new kind of treatment for hairy cell leukemia Sept 2018
  5. "Cambridge Antibody Technology Acquires Oncology Product Candidates from Genencor". Prnewswire.com. Retrieved 2010-05-12.
  6. https://web.archive.org/web/20090107000935/http://www.danisco.com/cms/connect/corporate/about+danisco/organisation/divisions/genencor/genencor_en.htm. Archived from the original on January 7, 2009. Retrieved August 12, 2009. Missing or empty |title= (help)
  7. "Archived copy". Archived from the original on 2013-01-20. Retrieved 2013-05-17.CS1 maint: archived copy as title (link)
  8. "News Releases - National Cancer Institute". Press.nci.nih.gov. Retrieved 2010-05-12.
  9. "Cambridge Antibody Technology Announces Preliminary Results for the Year Ended 30 September 2005. | Goliath Business News". Goliath.ecnext.com. Retrieved 2010-05-12.
  10. http://www.ama-assn.org/resources/doc/usan/moxetumomab-pasudotox.pdf
  11. http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5997
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